Single-insertion, multiple sample biopsy device with integrated markers

• US 8,721,563 B2
• Filed: 08/28/2012
• Issued: 05/13/2014
• Est. Priority Date: 08/10/2005
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Taylor, Jon, Thompson, Stanley O., Coonahan, Timothy J., Gray, Gregory A.
• Primary Examiner(s): Szmal, Brian
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US13/596,701
• Publication Number:
  US 20120323140A1
• Time in Patent Office: 623 Days
• Field of Search: 600/562, 600564-568, 606/167, 606170-171, 604/164.01, 60416411-16412
• US Class Current: 600/564
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers

Abstract

The present invention provides for exemplary embodiments of a single-insertion, multiple sample biopsy device. Exemplary embodiments of a single-insertion, multiple sampling device with integrated marker release.

Claims

1. A method of sampling biological tissue with a biopsy device having a bulkhead coupled to a flexible member having at least one lumen at least partially disposed in a needle that extends along a longitudinal axis between a distal end and a proximal end, the method comprising:

capturing a biological sample in a longitudinal aperture defined on a circumference of the needle;

filling a trough defined by the interior surface of the needle disposed about the bulkhead with a bio compatible fluid; and

translating the flexible member having the at least one lumen and bulkhead through the interior of the needle to transport the biological sample, aided by the filling of the trough with the bio compatible fluid, from the distal to the proximal ends,

the flexible member having a first end and a second end and wherein only the first end of the flexible member is attached to the bulkhead, and the translating includes rotating a rotational member engaged with the flexible portion in a first rotational direction to wind a part of the flexible portion about the rotational member to cause an axial displacement of the bulkhead in a proximal direction within the needle, and rotating the rotational member in a second rotational direction to extend the part of the flexible portion from the rotational member to cause an axial displacement of the bulkhead in a distal direction within the needle.

2. A biopsy device, comprising:

a stylet having a distal end and a proximal end, and a longitudinal axis that extends between the distal end and the proximal end, the stylet having a sample opening and an interior volume adjacent the distal end, the sample opening providing access to the interior volume;

a longitudinal cutting member with a cutting edge, the cutting member configured to move with respect to the stylet such that the cutting edge can cross over the sample opening to cut a tissue sample from a host;

an elongate flexible member configured to define a fluid path and positioned inside the stylet and movable along the longitudinal axis;

a distal bulkhead at a distal end of the interior volume, the distal bulkhead being coupled to the elongate flexible member, the elongate flexible member having a first end and a second end wherein only the first end of the elongate flexible member is attached to the distal bulkhead; and

a transport subassembly having an engaging member configured to wind a portion of the elongate flexible member, the transport subassembly being coupled to the at least one bulkhead via the elongate flexible member and configured to move a tissue sample received proximal the distal bulkhead from the sample opening to the proximal end of the stylet by a rotation of the engaging member to wind the portion of the elongate flexible member around the engaging member to axially displace the at least one bulkhead along the longitudinal axis within the stylet.

3. The biopsy device of claim 2, further comprising a proximal bulkhead positioned proximal to the distal bulkhead in the stylet.

4. The biopsy device of claim 2, wherein the engaging member includes a motor-drivable pulley, the transport subassembly being configured to at least partly wrap the flexible member around the motor-drivable pulley.

5. The device of claim 2, the fluid path of the flexible member having at least one lumen, and further comprising a saline pump connected to the at least one lumen, the at least one lumen having an outlet in communication with the interior volume.

6. A single-insertion, multiple sample biopsy device, comprising:

a cannula forming at least part of an insertable biopsy needle having a longitudinal axis, the cannula having a distal end where samples are received and a proximal end where samples are recovered;

a shuttle mechanism including a distal bulkhead configured to be movable within the cannula, the distal bulkhead being connected to a fluid line, the fluid line having a flexible portion, the flexible portion of the fluid line having a first end and a second end wherein only the first end of the flexible portion is attached to the distal bulkhead; and

a mechanism having a rotational member configured to engage the flexible portion of the fluid line, the mechanism configured to rotate the rotational member in a first rotational direction to wind a part of the flexible portion about the rotational member to cause an axial displacement of the shuttle mechanism in a proximal direction, and the mechanism configured to rotate the rotational member in a second rotational direction to extend the part of the flexible portion from the rotational member to cause an axial displacement of the shuttle mechanism in a distal direction, thereby to selectively withdraw and advance the distal bulkhead within the cannula, and configured such that samples placed on a proximal side of the distal bulkhead are urged in the proximal direction by the axial displacement of the shuttle mechanism in the proximal direction.

7. The device of claim 6, wherein the fluid line has a proximal end that is connected to a vacuum pump.

8. The device of claim 6, wherein the fluid line has a proximal end that is connected to a saline pump.

9. The device of claim 6, further comprising a proximal bulkhead located proximally of the distal bulkhead and connected to the fluid line, a vacuum line opening to a distal side of the proximal bulkhead, the fluid line opening to a distal side of the distal bulkhead, the distal bulkhead having at least one opening configured to facilitate a flow from a distal side of the distal bulkhead backward toward a proximal side of the distal bulkhead.

10. The device of claim 6, further comprising a sample receiving chamber located at the proximal end of the cannula.

11. The device of claim 6, further comprising an intermediate sheath within the cannula, wherein the fluid line is connected to the distal bulkhead by a manifold that fluidly couples the fluid line to an annular space between the cannula and intermediate sheath.